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Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma

NCT03972046 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-10-19

No results posted yet for this study

Summary

This study will investigate whether the use of talimogene laherparepvec (T-VEC) in combination with BRAF/MEK inhibitor will result in durable regional and distant recurrence free survival in the neoadjuvant setting for treatment of advanced nodal BRAF mutant melanoma.

Conditions

  • Melanoma (Skin)
  • Melanoma Stage IIIb-IVM1a
  • Metastasis Skin
  • Tumor Skin
  • BRAF Gene Mutation

Interventions

DRUG

Talimogene laherparepvec (T-Vec)

Talimogene laherparepvec (T-Vec) up to 4mL subcutaneous injection

DRUG

Dabrafenib (BRAF Inhibitor)

Dabrafenib (BRAF Inhibitor) 150 mg by mouth twice a day

DRUG

Trametinib (MEK Inhibitor)

Trametinib (MEK Inhibitor) 2 mg by mouth once a day

Sponsors & Collaborators

  • TriHealth Cancer Institute

    collaborator UNKNOWN

  • TriHealth Surgical Institute

    collaborator UNKNOWN

  • TriHealth Ultrasound Department

    collaborator UNKNOWN

  • Bethesda North TriHealth Hospital

    collaborator UNKNOWN

  • Good Samaritan TriHealth Hospital

    collaborator UNKNOWN

  • TriHealth Inc.

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2020-02-03
Completion
2020-02-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03972046 on ClinicalTrials.gov